Concert Pharmaceuticals Achieves $2-Million Milestone From Avanir Pharmaceuticals


Concert Pharmaceuticals, Inc. recently announced it has achieved a $2-million milestone under its development and license agreement with Avanir Pharmaceuticals, Inc. for the progression of the clinical development of AVP-786. The milestone is a result of Avanir initiating dosing of patients in a Phase III clinical trial with AVP-786 for the treatment of agitation in patients with Alzheimer’s disease.

“We are very pleased that AVP-786 has advanced to Phase III clinical evaluation,” said Roger Tung, PhD, President and CEO of Concert Pharmaceuticals. “Agitation associated with Alzheimer’s disease is an important unmet medical need, with no currently approved treatments, that affects up to half of the 5.3 million patients in the US and their caregivers. We look forward to the continued progress of AVP-786 in this indication.”

The collaboration agreement between Concert and Avanir provides Avanir with worldwide rights to develop and commercialize AVP-786 and other deuterium-modified dextromethorphan (d-DM) compounds. Under the agreement, Concert is eligible to receive additional milestone payments based upon achievement of certain predefined regulatory and commercial targets. Avanir will continue to have overall responsibility for research, development, and commercialization of d-DM compounds, including AVP-786, and Concert is eligible to receive tiered royalties on worldwide sales of any products containing d-DM. The milestone announced here is the third development milestone Concert has earned under this agreement.

Avanir is a subsidiary of Otsuka America, Inc. (OAI), a holding company established in the U.S. in 1989. OAI is wholly owned by Otsuka Pharmaceutical Co., Ltd., a global healthcare company with the corporate philosophy: ‘Otsuka-people creating new products for better health worldwide.’

AVP-786 is a novel, next-generation investigational drug product consisting of a combination of deuterated (d6)-dextromethorphan (an uncompetitive NMDA receptor antagonist, sigma-1 receptor agonist and inhibitor of the serotonin (SERT) and norepinephrine (NET) transporters), and an ultra-low dose quinidine. Incorporation of deuterium into the dextromethorphan molecule has been shown to reduce first-pass liver metabolism. By having a lower rate of metabolism, deuterated (d6)-dextromethorphan requires a substantially lower level of quinidine (an inhibitor of the enzyme CYP 2D6) in the AVP-786 formulation than with the earlier generation. This may result in a reduced potential for drug interactions and cardiac effects. AVP-786 is an investigational drug not approved by the FDA.

Concert Pharmaceuticals is a clinical-stage biopharmaceutical company focused on applying its DCE Platform (deuterated chemical entity platform) to create novel small molecule drugs. This approach starts with approved drugs, advanced clinical candidates or previously studied compounds that have the potential to be improved with deuterium substitution to enhance clinical safety, tolerability, and efficacy. The company is developing a broad pipeline targeting CNS disorders, genetic diseases, renal disease, inflammatory diseases, and cancer. For more information, visit www.concertpharma.com.